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Clinical Trials/NCT02201082
NCT02201082CompletedNot Applicable

Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country15 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
15
Locations
1
Primary Endpoint
Urinary excretion of amikacin

Study Overview

Brief Summary

The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to 50 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Stable cystic fibrosis patients older than 16 y.o.
  • Pseudomonas aeruginosa colonization
  • Hypersecretion

Exclusion Criteria

  • Kidney failure
  • No pregnancy

Arms & Interventions

Nebulization and airway clearance technique

Experimental

nebulization combined to airway clearance

Intervention: Airway clearance technique (Procedure)

Nebulization and airway clearance technique

Experimental

nebulization combined to airway clearance

Intervention: Amikacin nebulization (Drug)

Nebulization

Active Comparator

nebulization

Intervention: Amikacin nebulization (Drug)

Outcomes

Primary Outcomes

Urinary excretion of amikacin

Time Frame: 24h after the nebulization

Pharmacokinetic study of the urinary excretion of amikacin after nebulization

Secondary Outcomes

  • Amikacin concentration into the sputum(At the end of the nebulization, an expected average of 20 minutes)

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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